Global Sterility Assurance Lead

CSL; Bradley (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

CSL seeks a Global Sterility Assurance Systems & Standards Lead to build and govern sterility programs across our biotech manufacturing network. You will define sterility standards, policies, and quality systems aligned with cGMP, EU, and FDA requirements.

The role oversees aseptic processing controls, contamination control strategies, and validation for sterile products, partnering with sites to harmonize procedures and remediate gaps.

Qualifications

• Define and maintain sterility standards, policies, and quality systems aligned with cGMP, EU, and FDA requirements.
• Oversee aseptic processing controls, contamination control strategies, and validation for sterile products.

Responsibilities

• Build and govern sterility programs across our global biotech manufacturing network.
• Lead global sterility initiatives, support inspections/audits, and mentor teams to ensure safe, compliant therapies.

Job description

CSL is seeking a Global Sterility Assurance Systems & Standards Lead to build and govern world‑class sterility programs across our global biotech manufacturing network. In this role, you will define and maintain sterility standards, policies, and quality systems aligned with cGMP, EU, and FDA requirements. You will oversee aseptic processing controls, contamination control strategies, and validation for sterile products, partnering with sites to harmonize procedures and remediate gaps. The role provides global leadership, supports inspections and audits, drives continuous improvement, and mentors teams to ensure safe, compliant therapies for patients worldwide.